|- candidate number||21754|
|- NTR Number||NTR5022|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||6-mrt-2015|
|- Secondary IDs||UVA2012-5619 NL51444.018.14|
|- Public Title||Tailored clinical work related support for patients with gastro intestinal cancer |
|- Scientific Title||Gastro Intestinal cancer patients Receiving Occupational support Near and After diagnosis|
|- hypothesis||In the intervention group patients with GI cancer and work-related problems will receive tailored support which will lead to a more successful return to work compared to the control group of patients with GI cancer and work -related problems receiving usual care.|
|- Healt Condition(s) or Problem(s) studied||Gastro intestinal cancer, Return to work, Work functioning|
|- Inclusion criteria||Patients with a primary diagnosis of GI cancer|
- Small Intestine
Age between 18 and 63 years old
In paid employment or self-employed at time of diagnosis
Patients on sick leave (partly or entirely) as a result of related- work problems due to cancer
Treatment with a curative intent
Patients with sufficient knowledge of the Dutch language (able to understand, speak, read or write)
Written informed consent
|- Exclusion criteria||Severe mental disorder or other severe co- morbidity |
Patients who will receive primary cancer treatment at another hospital than hospital of recruitment
Patients who visit the hospital for a second opinion
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||23-mrt-2015|
|- planned closingdate||30-jul-2018|
|- Target number of participants||310|
|- Interventions||Intervention: tailored support for work- related problems
Because work- related problems could differ in severity, the intervention is split into three types of supports namely, support A, support B and support C. Within these different supports the health care discipline that provide the supportive care is different. In support A that will be an oncological nurse, in support B an occupational physician (specialized in RTW of oncological patients) and in support C there will be a multidisciplinary team (including at least an oncological nurse, the treating physician and an oncological occupational physician) that discuss the work- related problems. |
Patients are referred to a tailored support in the intervention on the basis of factors that are scored in patient questionnaires within the following categories; clinical history, work, work limitations and health status.
|- Primary outcome||The primary outcome parameter in this study is return- to- work (RTW). |
RTW is defined as time to partial or full RTW, meaning the number of calendar days between first day sick leave and first day at work. The patient must have returned to work (part time or full time) for at least 4 weeks successively.
|- Secondary outcome||-Work ability |
Work ability will be assessed with the first three questions of the Work Ability Index (WAI), using a 10-point scale. These questions concerns the evaluation of current work ability compared to their life time best and current physical and mental work ability with respect to their job demands.
Work limitations will be measured with the Work Limitation Questionnaire (WLQ), using a 5-point scale. This questionnaire evaluates the work disability and productivity (loss) in people with health problems. This questionnaire consists four subscales (25 items); work scheduling, physical demands, mental demands/ social demands and output demands.
-Quality of life
Quality of life (QoL) will be assessed with the SF-12 (12 items) and the EORTC QLQ-C30 (30 items). We are using two questionnaires to measure QoL; with the SF- 12 we could compare the participants in this study with the normal population and with the QLQ-C30 we could compare the QoL of patients with GI cancer against patients with other cancer diagnosis. These questionnaires provide insight in participants’ health, feelings and the ability to carry out usual activities.
Direct and indirect costs including:
Costs to carry out the intervention (payment of the disciplines for the intervention meetings /nurse training) [euro’s]
Days of hospital admission [days]
Work adjustments [e.g. no adjustments/reduction working hours/ other tasks plus open question]
|- Timepoints||The supportive care consists three counselling meetings.
The first meeting:
Is scheduled before the start of the treatment.
The second meeting:
Will be scheduled in consultation between patient and the supporting discipline after the first meeting (depending on diagnosis / treatment and preferences of the patient) and with a maximum of 3 – 6 months after the first meeting.
The third meeting
If there is an indication, will be scheduled on request / indication of patient and / or the supporting discipline of the second meeting (depending on diagnosis / treatment and preferences of the patient) and with a maximum of 6- 9 months after the first meeting.
Patients will fill in 5 questionnaires
|- Trial web site|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||MSc. AnneClaire Zaman|
|- CONTACT for SCIENTIFIC QUERIES||MSc. AnneClaire Zaman|
|- Sponsor/Initiator ||KWF Kankerbestrijding|
(Source(s) of Monetary or Material Support)
|Coronel Institute for Occupational and Environmental Health, Academic Medical Center (AMC), Amsterdam, KWF Kankerbestrijding|
|- Brief summary||This study concerns about the psychological health of cancer patients, for which sustaining at or returning to work is important. Earlier research shows that early support is needed, but that no interventions exist for supporting patients with GI cancer and work- related problems early in the process of diagnosis and treatment. Therefore we have developed an in- hospital program to support the RTW process for GI cancer patients. The program offers tailored support varying the severity of work- related problems of GI cancer patients. The (cost)-effectiveness of the intervention will be determined in a multicentre Randomised Controlled Trial. It will contribute as a foundation for optimising future tailored work- related interventions in cancer care. The intention is to implement the intervention if it has been shown effective. |
|- Main changes (audit trail)|
|- RECORD||6-mrt-2015 - 21-jun-2017|